Genmab (GMAB) Stock News

Genmab (GMAB) announced promising results from the Phase 1b/2 EPCORE NHL-2 trial evaluating epcoritamab combination therapy in relapsed/refractory DLBCL patients. The study showed an impressive 87% overall response rate and 65% complete response rate when epcoritamab was combined with R-ICE in patients eligible for autologous stem cell transplantation. At six months, 81% of responses were ongoing, 74% of patients remained progression-free, and patient survival was 100%. The safety profile was manageable, with mainly low-grade adverse events. The therapy demonstrated particularly strong results in high-risk patients who progressed rapidly after initial treatment, achieving an 85% overall response rate. This investigational combination therapy shows potential as a bridge to ASCT, with 65% of patients proceeding to transplantation.

Genmab announced promising Phase 1/2 trial results for rinatabart sesutecan (Rina-S) in treating advanced endometrial cancer. The study showed a 50.0% confirmed objective response rate at 100 mg/m2 dosage, including two complete responses, in heavily pre-treated patients. The median duration of response was not reached after 7.7 months follow-up. The trial involved 64 patients who received either 100 mg/m2 (n=22) or 120 mg/m2 (n=42) doses. The 120 mg/m2 cohort showed a 47.1% response rate. Common side effects included diarrhea, shortness of breath, and urinary tract infection, with serious adverse events occurring in 31.8% of patients at 100 mg/m2 and 50.0% at 120 mg/m2. Notably, no ocular toxicities, neuropathy, or Interstitial Lung Disease were observed, which are typically common with antibody-drug conjugates.

Genmab (GMAB) will present new research data at the 2025 ASCO Annual Meeting from May 30 to June 3 in Chicago. Key highlights include:

- First disclosure of Phase 1/2 trial results for rinatabart sesutecan (Rina-S®), a novel antibody-drug conjugate, in patients with recurrent/advanced endometrial cancer

- Presentation of long-term follow-up data from the Phase 1/2 EPCORE™ NHL-1 study of epcoritamab in patients with relapsed/refractory DLBCL, focusing on patients maintaining complete response at 2 years

The company will host a virtual investor update on June 2 at 4:00 PM CDT to review the Rina-S data. The presentations demonstrate Genmab's commitment to developing alternative treatment options, particularly for endometrial cancer, which has rising mortality rates and limited treatment options.

Genmab (NASDAQ: GMAB) announced the presentation of 14 abstracts evaluating epcoritamab, their T-cell engaging bispecific antibody, at the 2025 European Hematology Association Congress. The presentations will showcase data across multiple treatment settings for diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Key highlights include:

Two oral presentations will feature data from:

• EPCORE NHL-2 trial: evaluating epcoritamab plus R-ICE in relapsed/refractory DLBCL patients
• EPCORE NHL-5 trial: studying epcoritamab plus pola-R-CHP in previously-untreated DLBCL patients

Additional notable presentations include three-year follow-up data from the EPCORE NHL-1 and NHL-3 trials for epcoritamab monotherapy in R/R DLBCL and FL patients. The research will also be presented at the 18th International Conference on Malignant Lymphoma in Lugano, Switzerland.

Genmab (GMAB) plans to submit a supplemental Biologics License Application (sBLA) to the FDA in H1 2025 for epcoritamab in combination with rituximab and lenalidomide (R²) to treat adult patients with relapsed/refractory follicular lymphoma. The submission is backed by positive Phase 3 EPCORE FL-1 trial results, which met one of its dual primary endpoints with a statistically significant overall response rate (p-value < 0.0001). The safety profile was consistent with known profiles of individual treatments, with no new safety signals observed. Epcoritamab is currently FDA-approved as a monotherapy for R/R FL after two or more lines of systemic therapy, but the combination therapy is not yet approved in any territory.

Genmab A/S (NASDAQ: GMAB) announced that the European Commission has approved TIVDAK® (tisotumab vedotin) for treating adult patients with recurrent or metastatic cervical cancer who experienced disease progression after systemic therapy. TIVDAK is the first and only antibody-drug conjugate (ADC) approved for this indication in the EU.

The approval is based on the Phase 3 innovaTV 301 trial results, where TIVDAK demonstrated:

• 30% reduction in death risk compared to chemotherapy
• Median overall survival of 11.5 months vs 9.5 months for chemotherapy
• 33% reduction in disease progression risk

Common adverse reactions (≥25%) included peripheral neuropathy (39%), nausea (37%), epistaxis (33%), conjunctivitis (32%), alopecia (31%), anaemia (27%), and diarrhoea (25%).

TIVDAK® (tisotumab vedotin) has received approval from Japan's Ministry of Health, Labour and Welfare for treating advanced or recurrent cervical cancer that has progressed after chemotherapy. This marks a significant milestone as TIVDAK becomes the first and only antibody-drug conjugate (ADC) approved for cervical cancer patients in Japan.

The approval is supported by the global Phase 3 innovaTV 301 trial results, which demonstrated superior overall survival compared to chemotherapy. The study showed a 30% reduction in risk of death, with median overall survival of 11.5 months for TIVDAK versus 9.5 months for chemotherapy. The trial included 502 patients, with 101 being Japanese.

Common adverse reactions, observed in 87.6% of 250 treated patients, included conjunctivitis (30.4%), nausea (29.2%), peripheral sensory neuropathy (26.8%), alopecia (24.4%), and epistaxis (22.8%).

Genmab A/S (GMAB) reported updated data from Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), showing promising results in treating advanced ovarian cancer. With a median follow-up of 48 weeks, Rina-S at 120 mg/m2 demonstrated:

• Confirmed objective response rate (ORR) of 55.6%
• Disease control rate (DCR) of 88.9%
• Median duration of response (mDOR) not reached
• Complete responses in 4 patients (2 confirmed, 2 unconfirmed)
• Confirmed partial responses in 8 patients (44.4%)

At 100 mg/m2, the study showed a 22.7% ORR and 86.4% DCR. Common side effects included anemia, nausea, and neutropenia. The 120 mg/m2 dose has been selected for further evaluation in ongoing Phase 2 RAINFOL-01 and Phase 3 RAINFOL-02 trials for platinum-resistant ovarian cancer (PROC).

Genmab (Nasdaq: GMAB) announced that Johnson & Johnson (J&J) has declined to exercise its option for a worldwide license to develop, manufacture, and commercialize HexaBody-CD38. Following this decision and a portfolio evaluation, Genmab will discontinue further clinical development of the drug.

The Phase 2 expansion study comparing HexaBody-CD38 with DARZALEX FASPRO® in multiple myeloma patients showed an overall response rate (ORR) of 55% for HexaBody-CD38 versus 52% for daratumumab. Very good partial response rates were 29% vs. 17%, and complete response rates were 7% vs. 2%. Common treatment emergent adverse events included neutropenia, infusion-related reactions, anemia, and thrombocytopenia.

Despite promising clinical data validating the HexaBody platform's potential, Genmab will focus on its existing pipeline, including EPKINLY® and two wholly owned assets in Phase 3 development: rinatabart sesutecan and acasunlimab. The company maintains its 2025 Financial Guidance.